ICP-332 in Subjects with Moderate to Severe Atopic Dermatitis

Last updated: January 9, 2025
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Dermatitis, Atopic

Atopic Dermatitis

Skin Infections/disorders

Treatment

ICP-332 Placebo Tablets

ICP-332 Tablets

Clinical Study ID

NCT06775860
ICP-CL-00604
  • Ages 18-75
  • All Genders

Study Summary

A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects between 18 and 75 years of age.

  2. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for atleast 1 year

  3. Documented recent history of inadequate response to TCS or TCI, or for whom topicaltreatments are otherwise medically inadvisable.

  4. Subjects must meet the following criteria for disease activity:

  • Eczema Area and Severity Index (EASI) score ≥ 16 ;

  • (Body Surface Area )BSA affected by AD ≥ 10% ;

  • (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;

  • Baseline weekly average of daily Worst Pruritus NRS ≥ 4.

  1. Women of childbearing potential (WOCBP) and Men must agree

  2. Women of childbearing potential (WOCBP) and Men must agree to contraception. 6.Willing and able to comply with scheduled visits, treatment plan, laboratory tests,and other study procedures.

Exclusion

Exclusion Criteria:

  1. Lack of response or inadequate response to prior treatment with any JAK inhibitorfor AD.

  2. Other active skin diseases or skin infections requiring systemic treatment or wouldinterfere with appropriate assessment of atopic dermatitis lesions.

  3. Pregnant or breastfeeding females.

  4. History of any clinically major diseases, with the exception of atopic dermatitis.

  5. Consideration by the Investigator, for any reason, that the subject is an unsuitablecandidate to receive ICP-332 or participate in this study.

Study Design

Total Participants: 552
Treatment Group(s): 2
Primary Treatment: ICP-332 Placebo Tablets
Phase: 3
Study Start date:
November 14, 2024
Estimated Completion Date:
December 25, 2026

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Site Not Available

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241000
    China

    Active - Recruiting

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing 100730
    China

    Site Not Available

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 102218
    China

    Site Not Available

  • Capital Medical University Affiliated Beijing Chaoyang Hospital

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Capital Medical University Affiliated Beijing Friendship Hospital

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing, Chongqing 400021
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400016
    China

    Site Not Available

  • The Affiliated Union Hospital of Fujian Medical University

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian 361021
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong 510091
    China

    Active - Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Zhongshan University Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Yuebei People's Hospital

    Shaoguan, Guangdong 512026
    China

    Active - Recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong 518035
    China

    Active - Recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi 545006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan 570102
    China

    Site Not Available

  • The People's Hospital of Haikou City

    Haikou, Hainan 570203
    China

    Site Not Available

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei 067000
    China

    Site Not Available

  • Affiliated Hospital of Hebei University of Engineering

    Handan, Hebei 056002
    China

    Active - Recruiting

  • Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471000
    China

    Site Not Available

  • Nanyang First People's Hospital

    Nanyang, Henan 473010
    China

    Site Not Available

  • Sanmenxia Central Hospital

    Sanmenxia, Henan 472000
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Jingzhou Central Hospital

    Jingzhou, Hubei 434020
    China

    Site Not Available

  • Wuhan Central Hospital

    Wuhan, Hubei 430014
    China

    Site Not Available

  • Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430071
    China

    Site Not Available

  • Central South University Xiangya Hospital

    Changsha, Hunan 410008
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010050
    China

    Site Not Available

  • Changzhou First People's Hospital

    Changzhou, Jiangsu 213003
    China

    Active - Recruiting

  • Sir Run Run Hospital, Nanjing Medical University

    Nanjing, Jiangsu 211166
    China

    Site Not Available

  • Yancheng First People's Hospital

    Yancheng, Jiangsu 224001
    China

    Site Not Available

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi 341000
    China

    Active - Recruiting

  • Affiliated Hospital of Jiujiang University

    Jiujiang, Jiangxi 332000
    China

    Active - Recruiting

  • Jiangxi Provincial Dermatology Hospital

    Nanchang, Jiangxi 330001
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Meihekou Central Hospital

    Meihekou, Jilin 135000
    China

    Site Not Available

  • Shenyang Hospital of Integrated Traditional Chinese and Western Medicine (Shenyang Seventh People's Hospital)

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Zhongyi Northeast International Hospital Co., Ltd.

    Shenyang, Liaoning 110179
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi 710068
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Shandong Provincial Dermatosis Hospital

    Jinan, Shandong 250022
    China

    Site Not Available

  • Jining First People's Hospital

    Jining, Shandong 272011
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266003
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai, Shanghai 200080
    China

    Site Not Available

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai 200443
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai 200072
    China

    Site Not Available

  • Taiyuan Central Hospital

    Taiyuan, Shanxi 030009
    China

    Site Not Available

  • Yuncheng Central Hospital

    Yuncheng, Shanxi 440000
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan 610017
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine

    Tianjin, Tianjin 300120
    China

    Site Not Available

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • The Third People's Hospital of Hangzhou

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Jiaxing First Hospital

    Jiaxing, Zhejiang 314001
    China

    Site Not Available

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang 314000
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315010
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • The Fourth Affiliated Hospital, Zhejiang University School of Medicine

    Yiwu, Zhejiang 322000
    China

    Site Not Available

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